Assess the safety profile, to determine the maximum tolerated dose and Recommended Phase Two Dose of ABT-199 when administered in combination with rituximab (R) in subjects with relapsed chronic lymphocytic leukemia and small lymphocytic lymphoma.

Determination of the maximum tolerated dose of ABT-199 when administered with Bendamustine and Rituximab in subjects with relapsed or refractory non-Hodgkin's lymphoma

Determination of peak concentration (Cmax), trough concentration (Ctrough) and/or area under the concentration versus time curve (AUC) of ABT-199, Bendamustine and Rituximab in the dose escalation cohort

Number of participants with adverse events as a measure of safety and tolerability

(and 5 more...)

60

All

18 Years to 99 Years (Adult, Older Adult)

NCT01594229

M12-630

May 21, 2012

October 26, 2020

October 26, 2020

May 9, 2012

October 11, 2018

Ucsd /Id# 67350La Jolla, California, United States

University of California, Los Angeles /ID# 67343Los Angeles, California, United States

Step A : The occurrence of unacceptable toxicity of the combination of GA101 and Ibrutinib during the first cycle of treatment

Step B : The occurrence of unacceptable toxicity of the combination of GA101 and Ibrutinib plus GDC-0199 during the cycle 2 in terms of Dose-Limiting Toxicities (DLTs) of the studied combination to establish the Recommended Phase 2 Dose (RP2D).

Step C : The occurrence of unacceptable toxicity of the combination of GA101 and Ibrutinib and GDC-0199 at the end of the cycle 2.

Progression-Free Survival (PFS) Based on Investigator Assessment (Using IWCLL Criteria), Defined as the Time From Randomization to the First Occurrence of Progression, Relapse or Death From Any Cause

PFS Based on Institutional Review Committee (IRC)-Assessments, Defined as the Time From Randomization to the First Occurrence of Progression or Relapse or Death From any Cause

Percentage of Participants with an Overall Response of Complete Response (CR), CR with Incomplete Bone marrow Recovery (CRi), or Partial Response (PR), as Determined by the Investigator at Completion of Treatment According to IWCLL Criteria

(and 21 more...)

445

All

18 Years and older (Adult, Older Adult)

NCT02242942

BO253232014-001810-24CLL14

December 31, 2014

August 17, 2018

September 1, 2021

September 17, 2014

December 25, 2018

Banner MD Anderson Cancer CenterGilbert, Arizona, United States

City of HopeDuarte, California, United States

San Diego Pacific Hematology AssocatesEncinitas, California, United States

Incidence of toxicities defined as prolonged neutropenia or thrombocytopenia lasting > 42 days; febrile neutropenia; hospitalization due to infection; early death; major bleeding due to thrombocytopenia